Source: European Medicines Agency (EU) Revision Year: 2021 Publisher: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
Spedra 50 mg tablets.
| Pharmaceutical Form |
|---|
|
Tablet. Pale yellow oval tablets, debossed with “50” on one side. |
Each tablet contains 50 mg of avanafil.
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Avanafil |
Avanafil is a highly selective and potent, reversible inhibitor of cyclic guanosine monophosphate (cGMP)-specific phosphodiesterase type 5. When sexual stimulation causes the local release of nitric oxide, inhibition of PDE5 by avanafil produces increased levels of cGMP in the corpus cavernosum of the penis. This results in smooth muscle relaxation and inflow of blood into the penile tissues, thereby producing an erection. |
| List of Excipients |
|---|
|
Mannitol |
PVC/PCTFE/Aluminium perforated unit dose blisters in cartons of 4x1, 8x1 and 12x1 tablets.
Not all pack sizes may be marketed.
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A., 1, Avenue de la Gare, L-1611 Luxembourg, Luxembourg
EU/1/13/841/001-003
EU/1/13/841/012-014
Date of first authorisation: 21 June 2013
Date of latest renewal: 23 April 2018
| Drug | Countries | |
|---|---|---|
| SPEDRA | Austria, Australia, Cyprus, Estonia, Spain, Finland, France, Hong Kong, Croatia, Ireland, Italy, Lithuania, Netherlands, New Zealand, Poland, Romania, United Kingdom |
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